Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

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• JSON

: Product Name Types Code Types - XML Representation

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="cmc-product-name-types"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">PROP<a name="cmc-product-name-types-PROP"> </a></td><td>Proprietary</td></tr><tr><td style="white-space:nowrap">NON<a name="cmc-product-name-types-NON"> </a></td><td>Non-Proprietary</td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.16.2"/>
  </identifier>
  <version value="1.0.0-ballot"/>
  <name value="CmcProductNameTypes"/>
  <title value="Product Name Types Code Types"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-04-04T12:53:15+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="brr@lists.HL7.org"/>
    </telecom>
  </contact>
  <description
               value="Indicates patent or trademark status. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide.  These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems"/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="2"/>
  <concept>
    <code value="PROP"/>
    <display value="Proprietary"/>
  </concept>
  <concept>
    <code value="NON"/>
    <display value="Non-Proprietary"/>
  </concept>
</CodeSystem>